Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

Novo Nordisk A/S87 enrolled

Overview

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes (diagnosed more than 12 months ago) * HbA1c greater than 7.0 and less than 12.0% at screening * Currently on any OAD in more than 3 months ago * BMI (Body Mass Index) less than 35kg/m2 Exclusion Criteria: * Previous treatment with insulin in more than 7 days within the last 3 months * Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

Locations (1)

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20

Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20

Time frame: week 0, week 20

Secondary Outcomes

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12

Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline

Time frame: week 0, week 12

Change in Fasting Plasma Glucose (FPG)

Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20

Time frame: week 0, week 12, week 20

Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%

Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%

Time frame: week 12, week 20

Occurence of Hypoglycaemic Episodes

Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.

Time frame: weeks 0-20

Data from ClinicalTrials.gov

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